Confirmation Review

Stimulation of murine peritoneal macrophages with IFNy and LPS induced NO synthesis and activated IRE binding by IRP-1 and IRP-2. This activation is NO dependent and accompanied by a loss of the aconitase activity of IRP-1. This was also shown to occur in other cell types, such as the erythroid cell line K562, rat brain slices and mouse fibroblast lines and did not require cytokine stimulation. The activating effects of NO may depend on a direct interaction with the 4Fe-4S cluster or a slow effect on the low-molecular-weight iron pool. Activation of IRP-2 by LPS and IFN-y has not been universally confirmed (reviewed by Cairo and Pietrangelo, 2000). 

Lactic acidosis can occur after the use of intravascular iodinated contrast agents in patients taking metformin. Metformin is excreted by the kidneys, and renal insufficiency can lead to its retention, which can cause fatal lactic acidosis. The manufacturers have recommended that metformin should be withdrawn for 48 hours before and 48 hours after the administration of intravascular contrast media, which can cause renal damage, and treatment should not be restarted until normal renal function is confirmed. Reviews of reported cases of lactic acidosis after contrast administration have shown that there was pre-existing renal impairment in all cases. A retrospective evaluation of patients taking metformin who underwent... 

The note refers to part 2, here verifications are a mayor input for the Confirmation Reviews which is important input for the confirmation of the functional safety of the entire ITEM . 

Even more important is the trace for the requirement (g), the level of compliance. This requirement is a hidden requirement for the confirmation review in Part 2 of ISO 26262. Questioned could even be, if the assessment about the degree of compliant is not more a topic for a Functional Safety Assessment . The last requirement (h) leads to the result and the consequences of the entire verification activity. The decision must be taken if by the defined change management process iteration should be considered or if the result is sufficient to accept it, which is at the end also a typical assessment topic. 

Confirmation measures include confirmation reviews, functional safety audits and functional safety assessments ... 

ISO 26262 uses the term evaluate in connection with the functional safely audit and assessment and check for the confirmation reviews. The assessment character for the functional safety audits could come from checking whether the safety activities have been implemented as planned on the basis of the functional safety concept. 

NOTE 1 The confirmation reviews are performed for those work products that are specified in Table 1 and required by the safety plan. 

NOTE 2 A confirmation review includes the checking of correctness with respect to formality, contents, adequacy and completeness regarding the requirements of ISO 26262. 

NOTE 5 If the item changes subsequent to the completion of confirmation reviews or functional safety assessments, then these will be repeated or supplemented [see ISO 26262-8 —, 8.4.5.2 (change management)]. 

NOTE 7 Confirmation measures such as confirmation reviews and Junctional safety audits can be merged and combined with the functional safety assessment to support the handling of comparable variants of an item. 

Confirmation review of the hazard analysis and risk assessment of the item (see ISO 26262-3 —. Clause 5, ISO 26262-3 —, Clause 7 and if applicable, ISO 26262-8 —, Clause 5) independence with regard to the developers of the item, project management and the authors of the woik product I3 The scope of this review shall include the correctness of the deteimined ASILs, and QM ratings of the identified hazards for the item, and a review of the safety goals... 

Confirmation review of the completeness of the safety case (see 6.5.3) independence with regard to the authors of the safety case 10 II 12 13 Applies to the highest ASIL among the safety goals of the item... 

Confirmation Review is only mentioned in the tables of part 2. Apart from these tables there are no requirements for this kind of confirmation measure. But the objective of Confirmation Reviews is to build the bridge between other verifications as required or become necessary due to given requirements from the standard. The tables show that the key task should ensure the consistency and compliance of the norm according to ISO 26262 as well as that it is also a matter of standard compliance and work results and its documentation in defined work-products. However, most of the results also have to undergo verification according to ISO 26262, part 8, clause 9, which should show the consistency, correctness and completeness of essential work results. Essential however would be consistency checks of all work results, just like it is required later for the Safety Case. The tables label the confirmation reviews for the important work results ... 

Why the definition of the item, the functional safety concept, the component integration and their tests, the safety validation and the qualifications of hardware and software components do not undergo a confirmation review is unclear. However, some of these work results need to be verified. 

Since the Confirmation Reviews are placed between the verifications and the Assessment of Functional Safely, it would be advisable to combine these activities as well as possible. The necessary independency has already been achieved for the verifications through a different person, all content, which requires specific qualified personnel, should be included through verifications. The insufftcient independencies... 

If Confirmation Review during aU relevant steps during the activities according the safely lifecycle are planned, the final Functional Safety Assessment would be a respectively supplementing examination. It would complement the Safely Case by the safety validation and the assessment of the appropriateness of safety goals and their fulfillment for the confirmation of functional safety of the vehicle. 

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